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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB 2025-A00346-43 | Other Identifier | ANSM |
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This study aims to develop the use of a quantitative MRI (qMRI) approach in neuroimaging for MS patients.
To achieve this task the main goals of this study will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS Patients | Experimental |
| |
| Healthy Volunteers | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3T MRI | Other | For this intervention, subjects will undergo a 3T MRI. The duration of an MRI session will not exceed 1h30 |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessing the feasibility of an accelerated 3T and 7T qMRI approach | Sensitivity per unit of acquisition time (signal-to-noise ratio, SNR), short-term inter-examination reproducibility (intra-individual repeatability), as well as the minimum acquisition duration | Day 1 |
| To estimate standard values of qMRI biomarkers | qMRI metrics calculated over region of interests defined in white and gray matter, mean and standard deviation of qMRI parameters | Day 1 |
| To estimate normative inter-examination reproducibility of qMRI biomarkers | Inter-examination reproducibility (intra-individual repeatability) | During the first visit at Day 1 and during the second visit at day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate external reproducibility using 10 healthy subjects | Comparing healthy volunteers quantitative parameters with standard values on the same age (average +/- 1.96 standard deviation) | Day 1 |
| To Evaluate the clinical contribution of quantitative MRI on a population of 100 MS patients |
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Inclusion Criteria:
For healthy volunteers :
For MS patients
Exclusion Criteria:
For healthy subjects :
For MS patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean PELLETIER | Contact | 0491385941 | 33 | Jean.PELLETIER@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Gui de Chauliac | Montpellier | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 7T MRI | Other | For this intervention, healthy subjects and patients will undergo a 7T MRI. The duration of an MRI session will not exceed 1h30 |
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| Clinical examination of MS patients | Other | During this interevention, patients will be submitted to 2 tests the EDSS and the MSFC scores, assessing for physical and cognitive disabilities in patients. |
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| Neuropsychological testing of MS patients | Other | This interventions consists in submitting MS patients to diverses neurpsychological tests assessing various parameters: CSCT (Computerized Speed Cognitive Test) for speed of information processing. PASAT (Paced Auditory Serial Addition Test) fo executive functions, working memory and attention CVLT (California Verbal Learning Test) for verbal episodic memory BVMTR (Brief Visual Memory Test) for visual episodic memory Fluences for mental flexibility, attention, lexical access "Test des commissions" for Ecological evaluation of executive functions Moreover, patients will fill out auto-questionnaires of quality of life including: a self-questionnaire of laterality (EDINBURGH), fatigue (MFIS), depression (BECK), anxiety (STAI1 and STAI2), quality of life (MUSIQOL), sleep quality (PITTSBURGH) and cognitive complaint (PDQ) will be collected for the volunteers. |
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| Quality of life questionnaires | Other | This intervention consists in the completion diverse questionnaire assessing the quelity of life of the subject. These questionnaires include: a self-questionnaire of laterality (EDINBURGH), fatigue (MFIS), depression (BECK), anxiety (STAI1 and STAI2), quality of life (MUSIQOL), sleep quality (PITTSBURGH) and cognitive complaint (PDQ) will be collected for the volunteers. The completion of the self-questionnaires will take about 30 minutes. |
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Difference between MRI acquired data values and standard values (step 2), clinical contribution compared to the usual assessment (qualitative analysis). |
| Day 1 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |